Data updated: Mar 10, 2026
TOLBUTAMIDE
TOLBUTAMIDE
Approved 1974-07-10
11
Indications
--
Phase 3 Trials
51
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1974-07-10
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
DAVA PHARMS INC Teva PUREPAC PHARM Novartis WATSON LABS PHARMOBEDIENT VANGARD SUPERPHARM PARKE DAVIS ASCOT CHARTWELL RX ANI PHARMS ALRA
Active Ingredient: TOLBUTAMIDE
Website: ↗
TOLBUTAMIDE Approval History
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What TOLBUTAMIDE Treats
11 FDA approvalsOriginally approved for its first indication in 1974 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Jul 1974)
- • Approved indication (Jan 1979)
- • Approved indication (Apr 1979)
- • Approved indication (Aug 1979)
- • Approved indication (Nov 1979)
- • Approved indication (Feb 1980)
- • Approved indication (Mar 1980)
- • Approved indication (Jun 1980)
- • Approved indication (Feb 1981)
- • Approved indication (Mar 1981)
- • Approved indication (Nov 1984)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TOLBUTAMIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.